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The Court of Justice of the European Union ("CJ") ruled on 24 November 2011 that a marketing authorisation ("MA") granted for a multi-disease vaccine of which not all active ingredients fall within the basic patent, does not prevent the granting of a supplementary protection certificate ("SPC") for an active ingredient specified in the wording of the claims of the basic patent. Disharmony existed in Europe regarding the applicability of Regulation 469/2009 (the "SPC Regulation"') to "combination products". This ruling now means that innovative pharmaceutical companies can benefit from SPCs even when the patent does not protect the combination product for which an MA was granted. However, an SPC cannot be granted for the combination product as such but only for the patented part of the combination product.
Background: what are the conditions for obtaining an SPC?
SPCs are intended to compensate pharmaceutical companies for the loss of effective patent term caused by the delay in getting regulatory approval for medicinal products. An SPC follows and replaces the basic patent after the end of the general protection term and provides a maximum of five years of supplementary protection. The conditions for obtaining an SPC, as set out in art. 3 of the SPC Regulation, include that at the time of the application
(a) the product is protected by a basic patent in force
(b) a valid authorisation to place the product on the market as a medicinal product has been granted.
Additional conditions are:
(c) the product has not already been the subject of an SPC
(d) the MA referred to in (b) is the first authorisation to place the product on the market as a medicinal product.
What is the issue with combination products such as multi-disease vaccines and the SPC Regulation?
The SPC Regulation defines a 'product' as the active ingredient or combination of active ingredients of a medicinal product. If the (combination) product is (i) fully specified in a patent, and (ii) the MA was granted for the same (combination) product, no issue arises. However, a mismatch may occur between the 'product' that is patented and the 'product' for which an MA was granted. This issue is especially significant for multi-disease vaccines as is the case in both Medeva (C-322/10) and Georgetown (C-422/10). Due to public health policy, vaccines frequently contain a combination of active ingredients directed at a number of different diseases, so that only one injection is needed to carry out multiple immunisations. In those cases, an MA is granted for the multi-disease vaccine, being the product placed on the market. However, the patent usually only covers one active ingredient (or a combination of two) and does not 'disclose' the full combination. Here the issue arises whether an SPC can be granted in case the basic patent relates to A and the MA was granted for A + B.
Disharmony in Europe
In deciding on the availability of SPCs for combination products it was generally assumed that the concept 'the product' meant in art 3(a) with regard to patent protection needed to match 'the product' covered by the relevant MA mentioned in 3(b). Hence, the focus in these types of cases was not on the interpretation of the term 'product' (in article 3(b) and 3(a)) of the SPC Regulation but rather on the interpretation of the requirement 'protected by a basic patent' (of article 3(a)), using Farmitalia (C-392/97) as a guideline. In September 1999, the CJ in Farmitalia held that the question whether a product is protected by a basic patent as set out in art. 3(a) of the SPC Regulation must be answered based on the (national) rules governing that patent (in the absence of Community harmonisation of patent law). The question whether the wording of the claim of the basic patent (the 'disclosure test ') or the patent's scope of protection (the 'infringement test') should be decisive in determining whether the product for which the MA was given is "protected" by a basic patent according to 3(a) was left unanswered.
This lack of clarity resulted in conflicting interpretations by national patent offices and courts throughout Europe. In the Netherlands the disclosure doctrine was applied.
Questions referred to CJ
Medeva owned a patent relating to two antigens of the whooping cough virus. However, the vaccines marketed (and hence the MAs) contained additional active ingredients, directed at diphtheria, tetanus, meningitis and/or polio. Medeva applied for five SPCs with the UK Industrial Property Office ("IPO"), four covering combination vaccines and one limited to the two patented components only. The IPO rejected all SPCs, the first four for not complying with art. 3(a) of the SPC Regulation because a product containing multiple active ingredients was not considered to be protected by a basic patent that only claimed some of the ingredients. The SPC directed at only the two patented components was rejected for non-compliance with art. 3(b) as there was no valid MA in place because the MA contained more active ingredients than the product claimed in the patent. Medeva appealed and in the proceedings before the Court of Appeal, the questions were referred to the CJ concerning the interpretation of art. 3(a) and art. 3(b). In Georgetown, joined with this case by the CJ, the only question referred was the same as one of the questions in Medeva.
Why according to the CJ may combination products with not all active ingredient patented enjoy supplementary protection?
The CJ took a different approach altogether. Firstly, it ruled that article 3(a) of the SPC Regulation must be interpreted as precluding the competent IPO of a Member State from granting an SPC to active ingredients which are not specified in the wording of the claims of the basic patent relied on in support of the application for such a certificate. In other words, an SPC can only be obtained for the active ingredients that are specified in the wording of the claims of the patent. And in some respects applying the 'disclosure test' without clarifying the precise determination of fulfilment of this requirement of article 3(a), which is disadvantageous for the innovative pharmaceutical industry. The CJ motivates this by referring to art. 5 of the SPC Regulation which provides that the SPC confers the same rights as conferred by the basic patent and is subject to the same limitations and the same obligations.
Secondly, with regard to art. 3(b) of the SPC Regulation, the CJ ruled that this must be interpreted as meaning that, provided the other requirements laid down in article 3 are also met, that provision does not preclude the competent IPO of a Member State from granting an SPC for an active ingredient (or a combination of two active ingredients), specified in the wording of the claims of the basic patent relied on, where the medicinal product for which the MA is submitted in support of the application for an SPC contains not only that (combination of) active ingredient(s) but also other active ingredients. We understand this as follows: if the basic patent covers active ingredient A only, and the MA was granted for active ingredients A + B, an SPC can be granted for A (as also indicated in considerations 31 (Georgetown) and 38 (Medeva) of the decisions, citing the Explanatory Memorandum. However, if a patent claims the combination of A + B and an MA is granted for A + C, or A + B + C, an SPC cannot be granted for A in isolation.
Although the CJ decided on a narrow interpretation of 'protected' in art. 3(a), the patent owner is in some respects 'saved' by a creative interpretation of (the concept 'the product' in) article. 3(b): even if the MA is given for A + B and/or additional ingredients, and not for the 'product' A claimed by the basic patent as such, the relevant authorities may interpret this as a 'valid authorisation to place the product on the market as a medicinal product' as required for granting an SPC. Hence, contrary to what was generally assumed, the concept 'product' in art. 3(a) may differ from 'product' in 3(b), as long as the 3a-patented product is a subset of the 3b-MA product. For Medeva this decision means that only the fifth application for an SPC by Medeva covering only the two patented active ingredients could succeed.
Practical significance
This decision has far-reaching consequences. It means that innovative pharmaceutical companies can benefit from SPCs for their patents also if the relevant MA was granted for a combination product that is only partly disclosed by the patent relied on. For countries where the disclosure test was applied (such as the Netherlands) the possibility to obtain SPCs has been broadened. It also means that SPCs cannot be granted for active ingredients A + B, if the MA is in place for A + B and the wording of the claims of the patent only specify A. This means a limitation of the granting practice in countries where the infringement test was used (where SPCs for A + B were granted).
Following the CJ decision, this has already led to the Court of Rome ruling (on 25 November) that Novartis cannot invoke its (Italian) SPC granted for a combination product that was not fully disclosed by its patent. Several issues regarding both the application for SPCs and the protection granted by a valid SPC remain unresolved and are the subject of several other referrals to the CJ regarding the interpretation of the SPC Regulation. Medeva does provide possibilities for the pharmaceutical industry and companies should currently apply for SPCs as long as one of the active ingredients of the relevant MA is specified in the wording of the claims of the patent.
Of course, we would be more than pleased to discuss the practical consequences this decision by the CJ may have.